60
Participants
Start Date
September 17, 2025
Primary Completion Date
December 31, 2028
Study Completion Date
December 31, 2029
Fluzone High Dose Inactivated Influenza Vaccine
Fluzone High-Dose (Influenza Vaccine) for intramuscular use is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. The virus- containing allantoic fluid is harvested and inactivated with formaldehyde. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, octylphenol ethoxylate (Triton® X-100), producing a split virus. The split virus containing hemagglutinin (HA) antigen is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution. The Fluzone High-Dose process uses an additional concentration factor after the ultrafiltration step to obtain a higher HA antigen concentration. The purified split virus from the three strains included in the vaccine are produced separately and then combined to make the trivalent formulation.
Fluzone Standard Dose Inactivated Influenza Vaccine
Fluzone Standard Dose is a vaccine indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine.
RECRUITING
Vanderbilt University Medical Center, Nashville
Vanderbilt University Medical Center
OTHER